Postoperative Cognitive DysfunctionPhase 1/2NCT01700907
Optimization of Desflurane in Elderly Patients
A Phase 1/2 study testing Desflurane and Sevoflurane in people with Postoperative Cognitive Dysfunction, run by Sapporo Medical University at 1 site in Japan.
Trial summary
Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing. Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Desflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Feb 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients
Who cannot join
- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI>35)
Trial locations and contacts
1 site in 1 country.
Japan1 site
Sapporo Medical University, School of Medicine
Sappro, Hokkaido, 0608556
About this study
Official title: Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study
Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing.
Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia.
The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).
Read the detailed description
The objectives of this study is to compare the time to emergence and quality of recovery in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).
Inclusion Criteria:
- Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients
Exclusion Criteria:
- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI>35)
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Desflurane, Sevoflurane
- Keywords
- Postoperative cognitive dysfunction, elderly patients, long surgery
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called (2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane
The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
SevofluraneDrug
Also called 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane
The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
| Study group | Role | What they receive |
|---|---|---|
| group DES | Active comparator | The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. Receives: Drug: Desflurane |
| group SEVO | Active comparator | The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Time From the End of Anesthesia to Extubation
When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
Measured: Within 60 minutes after the end of anesthesia
Secondary outcomes (4)
The Time From the End of Anesthesia to Eye Opening
When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
Measured: Within 60 minutes after the end of anesthesia
The Time From the End of Anesthesia to Following Commands
When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
Measured: Within 60 minutes after the end of anesthesia
Cognitive Function
Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.
Measured: 24 hrs pre and postoperatively
The Incidence of Postoperative Delirium
The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.
Measured: from 15 minutes to 48 hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapporo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michiaki Yamakage, Sapporo Medical University
- Investigators
- Michiaki Yamakage, M.D.,PhD, Principal investigator, Sapporo Medical University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700907
- Sponsor's protocol ID
- DES-40-POCD
- Status last verified
- Nov 2014
- First submitted
- 30 Sep 2012
- Last updated
- 27 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study
- ClinicalTrials.gov ID
- NCT01700907
- Acronym / sponsor ID
- DES-40-POCD
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative cognitive dysfunction, elderly patients, long surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sapporo Medical UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 27 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing.
Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia.
The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).
Detailed description
The objectives of this study is to compare the time to emergence and quality of recovery in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).
Inclusion Criteria:
- Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients
Exclusion Criteria:
- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI>35)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group DES | Active comparator | Drug: DesfluraneThe patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. |
| group SEVO | Active comparator | Drug: SevofluraneThe patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients
Key exclusion criteria (1 listed)
- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI>35)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneAlso: (2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethaneThe patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. | Drug | group DES |
| SevofluraneAlso: 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propaneThe patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. | Drug | group SEVO |
Primary outcome
The Time From the End of Anesthesia to Extubation
Time frame: Within 60 minutes after the end of anesthesia
When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
4 secondary outcomes
The Time From the End of Anesthesia to Eye Opening
Time frame: Within 60 minutes after the end of anesthesia
The Time From the End of Anesthesia to Following Commands
Time frame: Within 60 minutes after the end of anesthesia
Cognitive Function
Time frame: 24 hrs pre and postoperatively
The Incidence of Postoperative Delirium
Time frame: from 15 minutes to 48 hrs postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiaki Yamakage, M.D.,PhD principal investigator
Sapporo Medical University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Desflurane and Sevoflurane in people with Postoperative Cognitive Dysfunction, run by Sapporo Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Time From the End of Anesthesia to Extubation (time frame: Within 60 minutes after the end of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2014; AzTrials last refreshed its copy on 26 Oct 2026.